A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Respiratory Events Requiring Intervention
研究概览
简要总结
Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and 3) no significant hemodynamic or respiratory changes when compared to a sedation combination of midazolam, fentanyl and propofol for sedation during third molar surgery.
详细描述
Intravenous sedation (IVS) is an integral aspect of the oral and maxillofacial surgeon's practice. For many minor oral surgical procedures, intravenous sedation is often necessary to manage patient anxiety and discomfort, while also facilitating a safe and efficient procedure in the outpatient setting. Ideally, sedative agents have anxiolytic, amnestic, and analgesic properties while maintaining cardiopulmonary stability. The medications used should allow for rapid onset of action, as well as a quick recovery, with minimal side effects.
Several pharmacologic agents are frequently used for conscious sedation in the oral surgery practice. These medications often include midazolam, fentanyl, ketamine and propofol, either alone or in conjunction with one another. While propofol and fentanyl have proved to be efficacious agents for use in intravenous sedation, they are not without associated side effects. Propofol has the potential to cause a quick progression from conscious sedation to general anesthesia, with the undesired effect of associated cardiovascular and respiratory depression. Decreased respiratory drive, hypotension, and dose-dependent bradycardia are often seen with opioid analgesics such as fentanyl.1,2 Ketamine can cause emergence delirium, increased salivation and pulmonary secretions, tachycardia, and post-operative nausea and vomiting (PONV).
Midazolam is a benzodiazepine that is an attractive agent for intravenous sedation due to its sedative, amnestic, and hypnotic properties. In addition, it is associated with very minimal cardiovascular and respiratory changes. However, midazolam lacks significant analgesic effects, and therefore is routinely used in conjunction with additional agents when used for procedural sedation. Though several studies have explored the use of midazolam as a sole anesthetic, very high doses are required for deep sedation. This can lead to dose-dependent respiratory depression, prolonged emergence and longer recovery time.
Dexmedetomidine (Precedex, Hospira, Inc., Lake Forest, IL) is a highly selective alpha2-adrenergic agonist that possesses hypnotic, sedative, anxiolytic, and analgesic properties. It is currently approved for use as a sedative agent in ICU patients, and has been proven a safe and effective agent for use during procedural sedation. In the central nervous system, the primary site of action of dexmedetomidine is the locus ceruleus, resulting in a level of sedation similar to natural sleep, associated with fast and easy arousal. It demonstrates relative hemodynamic stability with little effect on respiratory depression. Unlike propofol and fentanyl, dexmedetomidine's lack of adverse effects on respiration makes it an attractive agent for use during intravenous sedation in the oral and maxillofacial surgery practice.
Several studies involving dexmedetomidine exist in the oral and maxillofacial surgery literature. Dexmedetomidine has been compared as a substitute for midazolam, as well as propofol, in conscious sedation by several authors. For third molar surgery, dexmedetomidine was noted to preserve the respiratory rate and oxygen saturation throughout operation and recovery periods. Fan et al also found no significant differences in respiratory rate when comparing the two agents for conscious sedation. In comparison to midazolam, Ryu et al reported safe sedation without airway compromise and minimal effects on the respiratory system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
- •ASA Class I or II
- •English-speaking and Spanish-speaking subjects
排除标准
- •ASA Class III or higher
- •Patients taking alpha-2 agonists or benzodiazepines
- •Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
- •BMI greater than 30
- •History of or current substance abuse or alcoholism
- •History of mood-altering medications, tranquilizers, or antidepressants.
- •Pregnant females
研究组 & 干预措施
Propofol Group
Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.
干预措施: Propofol, Midazolam, and Fentanyl (Drug)
Dexmedetomidine Group
Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.
干预措施: Dexmedetomidine and Midazolam (Drug)
结局指标
主要结局
Respiratory Events Requiring Intervention
时间窗: During surgery
To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.
次要结局
- Surgeon Satisfaction - Survey(15 minutes following surgery)
- Respiratory Depression - Respiratory Rate(During the procedure, up to 40 minutes)
- Respiratory Depression - Oxygen Saturation(During the procedure, up to 40 minutes)
- Cooperation Scale(15 minutes following surgery)
- Hemodynamic Stability - Blood Pressure(During the procedure, up to 40 minutes)
- Postoperative Recovery Time - Duration of Procedure(During the procedure, up to 40 minutes)
- Reaction to Administration of Local Anesthesia(During the first injection of local anesthesia during surgery)
- Patient Satisfaction(30 minutes following surgery)
- Hemodynamic Stability - Heart Rate(During the procedure, up to 40 minutes)
- Postoperative Recovery Time - Time to Discharge(After the procedure until discharge, up to 45 minutes)
- Postoperative Recovery Time - Ambulation(After the procedure until ambulation, up to 20 minutes)
研究者
Patrick Nolan
Attending Oral Maxillofacial Surgery
Montefiore Medical Center
